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Study to Evaluate CCS1477 in Haematological Malignancies

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ClinicalTrials.gov Identifier: NCT04068597
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
CellCentric Ltd.

Brief Summary:
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Haematological Malignancy Acute Myeloid Leukemia Non Hodgkin Lymphoma Multiple Myeloma Drug: CCS1477 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The RP2D/MTD dose will be determined in Parts A and B. Parts C-E will run in parallel after the completion of Parts A and B.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy in Patients With Advanced Haematological Malignancies.
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: CCS1477 dose escalation NHL/MM Drug: CCS1477
Oral

Experimental: CCS1477 dose escalation AML/High risk MDS Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase NHL Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase MM Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase AML/High risk MDS Drug: CCS1477
Oral




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: Up to 12 months ]
    Treatment-related adverse events and serious adverse events

  2. Incidence of laboratory abnormalities [ Time Frame: Up to 12 months ]
    Laboratory abnormalities characterised by type, frequency, severity and timing


Secondary Outcome Measures :
  1. Response rate [ Time Frame: Up to 12 months ]

    Defined as number of patients who have a response according to

    • RECIL criteria (NHL)
    • IMWG criteria (Multiple myeloma)
    • ELN recommendations 2017 (AML)

  2. Duration of Response [ Time Frame: Up to 12 months ]
    Defined as the time from start of treatment until disease progression

  3. AUC of CCS1477 [ Time Frame: 35 days ]
    Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477

  4. Cmax of CCS1477 [ Time Frame: 35 days ]
    Maximum observed plasma concentration (Cmax) of CCS1477



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of consent
  • ECOG performance status 0-2
  • Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
  • Must have previously received standard therapy
  • Adequate organ function

Exclusion Criteria:

  • Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  • Patients should discontinue statins prior to starting study treatment
  • CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
  • Any evidence of severe or uncontrolled systemic diseases
  • Any known uncontrolled inter-current illness
  • QTcF prolongation (> 480 msec)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068597


Contacts
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Contact: Karen Clegg, PhD +44 7464547447 Karen.Clegg@cellcentric.com
Contact: Tomasz Knurowski, MD, MFPM +44 1252 842255 Tomasz.Knurowski@cellcentric.com

Locations
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United Kingdom
The Christie Hospital Recruiting
Manchester, United Kingdom
Contact: Tim Somervaille         
Sponsors and Collaborators
CellCentric Ltd.
Investigators
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Principal Investigator: Andrew Davies Southampton NCRI/CR UK Experimental Cancer Medicines Centre

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Responsible Party: CellCentric Ltd.
ClinicalTrials.gov Identifier: NCT04068597     History of Changes
Other Study ID Numbers: CCS1477-02
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site